Revision of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to Streamline Review Process for Human Gene Transfer Protocols

Notice Number: NOT-OD-16-076

Key Dates
Release Date: March 23, 2016

Related Announcements

Issued by
National Institutes of Health (NIH)


The purpose of this Notice is to inform the research community that the National Institutes of Health (NIH) is revising the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to incorporate the recommendations of the Institute of Medicine (IOM) regarding the review of human gene transfer protocols, as initially outlined by the NIH Office of Science Policy (OSP) in a Federal Register Notice issued on October 16, 2015 (80 FR 62543).

Following the solicitation of public comment on its original proposal, the NIH is amending the NIH Guidelines in the following areas:
(A) the criteria for selecting protocols for in-depth review and public discussion by the NIH Recombinant DNA Advisory Committee (RAC),
(B) the process by which human gene transfer protocols are reviewed and registered with the NIH, and
(C) the streamlining of the NIH protocol submission requirements under Appendix M-I-A of the NIH Guidelines.

The revisions to the NIH Guidelines are fully described in a Notice published in the Federal Register issued on March 22, 2016 (81 FR 15315). The NIH strongly encourages careful review of the Federal Register Notice to understand what will be expected of investigators and the roles of oversight bodies (such as an Institutional Biosafety Committee or an Institutional Review Board) involved in the conduct of human gene transfer research. Changes outlined in this Notice will become effective on April 27, 2016, after which RAC review of individual human gene transfer protocols will be limited to cases in which an oversight body determines that a protocol would significantly benefit from RAC review and has been determined to meet the new criteria as specified in the revised NIH Guidelines. Human gene transfer protocols may also be reviewed by the RAC if the NIH Director determines a protocol presents significant scientific, societal, or ethical concerns.


Please direct all inquiries to:

Office of Science Policy
National Institutes of Health